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RED 550

Preparation for Investigator-Initiated Drug and Device Studies


Sara Mumford, MBA, CIP
Associate Director
Institutional Review Board









This is a REd Asynchronous (online/self-paced) class.

Information and materials to prepare investigators and research personnel to initiate, manage and oversee a drug or device trial at the University will be presented. The Food and Drug Administration (FDA) Investigational New Drug (IND) and Investigational Device Exemption (IDE) requirements will be described. Topics such as additional investigator responsibilities, the IRB submission and approval process including pre-approval audit, and methods of continued study oversight will be discussed.

REd Asynchronous classes feature lessons and exercises designed to build competency and increase efficiency. Modules are accessible 24/7 and are all self-paced. All members of the University research community are invited to complete any online classes of interest.

Last Updated: 11/1/23